Friday, January 08, 2016

Private for-profit milk bank operations
now active in Australia, Cambodia
and the United States.

The dawn of 2016 promises a huge year for the sale of human milk, with four companies in the market in the US and one start-up in Australia. There is scant oversight of the rapid commodification of this precious human food and medicine. If the ideas and drive of nimble and ingenious entrepreneurs turn into new processes and products that could save fragile babies, this could be a good thing. But the no-holds barred marketing war under way is also eroding confidence in the existing donor human milk system, and even in mothers' own milk.

Sterile! Stringent standards! Unparalleled safety! 100 per cent natural! No additives or preservatives! Firms outdo themselves with breathless and sweeping marketing claims telling buyers their processing method is best and safest. Some aggressively disparage current standards for processing human milk, used by hundreds of milk banks around the world.

For years, California-based Prolacta was the only company making money selling human milk in the US. Its only competition was the struggling but growing network of not-for-profit milk banks that provide donor human milk for babies in need when a mother's own milk is not available. After a rocky start with troubles securing a reliable supply of milk and accusations of duping trusting donors who thought they were giving their milk to non-profit milk banks, Prolacta punted its founder Elena Medo and embraced a more sophisticated method of securing supply, first donating $1 to charities like March of Dimes for every ounce of milk given, and then setting up hospital-affiliated virtual milk collection fronts. Prolacta sells standardized human milk products at a higher price than the processing rate charged by the non-profits, and in order to convince hospitals to part with the extra cash, the company promises the most stringent safety measures in the business. The quiet implication is that non-profit donor milk isn't quite up to snuff, though there’s no evidence of that. Prolacta's top money-maker is its proprietary human-derived human milk fortifier, the only such product in the world. It increases survival chances of very low birth weight premature babies – at increased risk of sepsis, necrotizing enterocolitis, and other possibly fatal diseases when bovine-based fortifiers are used. At $180/oz the fortifier takes the concept of breast milk as liquid gold to a new level.

Medo claims "anything short of commercial sterility
is unacceptable" in the NICU

Seeing opportunity, Elena Medo regrouped after her ouster from Prolacta and set up a competing firm, Medolac, which takes advantage of Delaware's flexible public benefit corporation rules. Medo has upped the stakes by paying for human milk through the Oregon-based, crunchy, altruistic-sounding Mother's Milk Cooperative, which is controlled by her daughter, Adrianne Weir. Clearly stung by widespread criticism of profiting off the backs of women who were giving their milk freely to her Prolacta start-up, Medo and now Weir use careful language that positions their firms as altruistic social enterprises, run by women, run by moms, run by social entrepreneurs whose main goal is to better the lives of women and babies. Their talking points also push hard against the processing methods used by both Prolacta and the non-profit milk banks, Medo goes so far as to claim the only products that are safe for use in the NICU are sterile products - and that just happens to be the processing method she's chosen for her new venture. Medolac also sells lucrative human milk derivatives to researchers, and Medo also owns a separate company that sells instruments that test a mother's own milk to NICUs.

Only The Breast's Glenn Snow partnered with
Elena Medo days before researchers announced
bacterial contamination in milk traded on his site.

Enter Only The Breast, an Internet-based human milk brokerage with almost 50,000 women offering tens of millions of ounces of milk. CEO Glenn Snow partnered with Medo and announced the closure of the brokerage just a few days before the news that researchers found a high rate of bacterial contamination in milk traded on the site. Now, Snow has apparently decided to scrap the partnership and go it alone with his Nevada-based International Milk Bank, which promises stringent safety standards and a commercially sterile product that sounds very similar to Medo's process, and hints at a specialized "preemie milk. (The milk made by those who have given birth to a premature baby is more suited in composition for premature babies and its use may reduce the need for fortifiers – this is another market niche to be filled, especially if it can be shown that the human derived fortifier marketed by Prolacta isn't as important as its research suggests. If mother's own, or milk from another preemie mother is just as good, or better, poof goes the profit on Prolacta's $180/oz product.)

Nevertheless, Prolacta's only real competition so far remains the growing non-profit network of milk banks under the loose umbrella of associations that provide guidance, standards and accreditation. In the U.S. and Canada that guidance is provided by the Human Milk Banking Association of North America (HMBANA). In this AIDS-aware world, convincing the public and medical professionals of the safety and security of the global human milk supply has been a major preoccupation of milk banks. HMBANA is the accreditation body for North America and its milk banks use the tried-and-true Low Temperature Long Time (LTLT) method of pasteurization, or Holder method, to process donor human milk to control harmful pathogens. LTLT pasteurization is used by almost all milk banks around the world. (Norway offers screened, raw milk.) This gentle pasteurization heats milk to 62.5C and holds it there for 30 minutes, killing harmful pathogens but leaving many of the delicate nutrients and immune properties intact. The process is safe and universally understood. This was the most common method of pasteurization for cow's milk for many decades until the faster (and therefore more cost effective) industrial process known as High Temperature Short Time (HTST) was developed. In both types of pasteurization the resulting milk has a short shelf life and is shipped frozen, and kept refrigerated after thawing.

Medo questions safety of mother's own milk in NICU.

Medolac and the International Milk Bank promote an even higher temperature milk processing process, similar to UHT, which renders the milk sterile. Neither company has provided specific details on the process and won’t reveal resulting changes in nutritional and immune composition of the milk. Medolac and the International Milk Bank don't appear to have secured many, if any, contracts to sell their milk products to US hospitals, although Medolac's senior VP, Corporate Affairs, Doug Hawkins tells his Linked-In readers he "Achieved product adoption by over 100 hospitals across the nation." Both promote their sterile human milk as superior, saying Holder pasteurized milk has an unacceptable bacterial load. Medo disparages the use of pasteurized donor milk in the NICU claiming the only safe milk is sterile milk, and further, she suggests mother's own milk should be tested for intrinsic contamination.

Weir disparages non-profit milk banks on Linked-In.

Weir's recent blog post on Linked-In is a good example of this demonizing of non-profit donor milk in order to sell the product made by Medolac and the Mothers Milk Coop. Medolac likely chose this process in order to keep costs down as this shelf-stable milk is much cheaper to ship and can be stored at room temperature. They may have also been forced into this method of processing by Medo’s non-disclosure and non-competition agreements with Prolacta, now the subject of a lawsuit.

Neither Medolac nor International Milk Bank has made public any studies they may have done showing their products are as safe and effective as the standard pasteurization processes – a real concern if 100 hospitals are actually using this product instead of mother's own or pasteurized donor human milk. Medolac has been plagued by lawsuits like the one from Prolacta. It recently terminated its agreement with its distributor, referred to a "hostile takeover attempt," has been hounded by controversy over potential exploitation of its milk providers, and there are rumours of cash flow problems. International Milk Bank has so far kept a lower profile – so low it's not clear if it even has a product ready to sell.

Supply remains the hurdle for all providers of human milk. North American non-profit milk banks, which rely on altruistic donors to give away their excess milk, struggle with awareness and frequently resort to the crisis method of securing supply, with news outlets provided with images of empty freezers and pleas for urgent donations. When Medolac burst out of the gates with its new Mothers Milk Coop, it said it quickly secured 1 million ounces of milk with its offer of direct payment. This forced Prolacta, which relied on donors, to also pay up front for milk with its Tiny Treasures offering.

The emergence five years ago of more formalized milksharing networks using social media to connect donors directly with recipients is also seen as a threat to supply. Although researchers have not confirmed this (Gribble et al, Palmquist, Doehler), and many milksharing advocates also work to promote milk banks, at least one organization has called on women with milk to share be screened through their local milk bank, promising that the greater supply will result in a return of milk to the community at large. Eats on Feets founder Shell Walker is very critical of milk banks and doesn't allow mention of them on her sites, which raises ethical concerns about whether women interested in milksharing are able to make a truly informed choice about their milk donation options. Milksharing and milk banking advocates alike are concerned about the ethical implications of paying for milk – HMBANA issued a strong statement in December 2014 saying donation of milk is the only ethical way to collect the milk needed to provide for critically ill infants, and milksharing groups support only commerce-free activity on their sites.

What do the folks with milk in their breasts think about all this? The going rate in the US is $1/oz. This doesn't seem like a lot if you are only setting aside 2-5 oz a day, but Only The Breast's experience was that sellers had an average of 800 oz in the freezer. And Medolac found lactators are willing to ramp up their supply to significant amounts – it isn't uncommon to see reports of sales of 500-1000 ounces/month and more. With families taking in $500-$1000/month, it's easy to see how some could be exploited through a pay-for-milk system. When Medolac's Mothers Milk Coop didn’t appear to pay for all the milk it received, sellers complained on social media sites they would have to cancel holidays, forego birthday presents, and some said they feared they wouldn't be able to pay medical bills or rent or utilities. Some have also reported women who pump and provide milk for sale after they stop feeding it to their own children, and it's easy to see how someone else living in a home with a baby and a freezer stash of milk, desperate for food or rent money, might hoist that baby's milk supply right out of the freezer to convert it into quick cash on Kijiji or through Only the Breast.

And what happens if a woman becomes ill and her milk supply suddenly drops temporarily, but she still needs the cash for necessities - might she be tempted to top it up with some cow's milk from the fridge? Researchers assessing milk sold over the Internet via services like Only the Breast found about 10 per cent of the samples purchased were contaminated with cow’s milk. Prolacta and Medolac say they test for bovine protein to make sure that doesn't happen and Prolacta also uses DNA testing – which it says is one reason why its end products are so expensive. Medolac says DNA testing is unnecessary. Non-profit milk banks, with many years of experience, say altruistic giving doesn't come with these same adulteration issues.

The controversy over paying for human milk boiled over last year when Medolac announced it planned to target black women in cities like Detroit to augment its milk supply. Detroit has double the US rate of prematurity, but few of its hospitals provide human milk for babies in need, and there are no local milk banks for the black women of Detroit to donate their excess. Lack of access to mom's own milk or donor milk means more cases of necrotizing enterocolitis, the major single cause of death among premature infants. In Toronto when there was a delay in the launch of a milk bank, it was said 15 babies per year died for lack of access to donor human milk. How many babies die in Detroit each year because of lack of access to donor human milk?

Medolac's plan would have taken potential donor milk out of Detroit. Yet another startup wants to take milk out of Cambodia and sell it in the U.S. Ambrosia Labs, of Orem, Utah, announced in December 2015 it is paying Cambodian women between 50 cents and $1/oz for milk to be sold for at least nine times that to US customers. The Phnom Penh Post reports a US tariff ruling indicated Ambrosia plans to market the Cambodian milk as "a food product for infants and as a nutritional supplement for bodybuilders." Ambrosia has so far provided little detail about its processing method but it appears to be one of the standard pasteurizations. Mothers in Cambodia come into a local clinic to express their milk, which is certainly one way to cut down on both bacterial contamination and potential adulteration with the milk of another species. Ambrosia argues the pay is above the median daily wage in Cambodia, and it suggests its "worksite" is safer than many in that country.

Women should not be prohibited from doing whatever they want with their bodies and their breastmilk, including selling it. That doesn't mean it's ok to exploit of some of the world's poorest women and babies so wealthy families and bodybuilders (!) can have the best of the best nutrition. Activist Afrykayn Moon, who worked with many black breastfeeding advocates to force Medolac to back away from their Detroit plans, has noted the 2015 Australian-American film Mad Max Fury Road's Milk Farm riff may not be that far off.

Ironically, Australia is the second country after the US to see the launch a for-profit business to purchase milk. This proposal introduces yet another novel processing method. In its startup phase the Australian Breast Milk Bank called for breastfeeding mothers to donate 150 litres of milk so it could test high pressure processing, which it says will be superior to pasteurization. There is actually some research on this process, unlike that used by Medolac, but it's far from proven. This is a brand new venture and the business model isn't firm, but an "ethical, reliable and socially just business model" is promised. ABMB also wants to work on a concentrated human milk product, or fortifier - no surprise since that appears to be where the big money is. Medolac also promises a fortifier, which could end Prolacta's monopoly.

The sad truth is, more than half the premature babies in the US who need access to donor milk don't have it. Human milk is widely considered a "scarce commodity" – though milksharing advocate Emma Kwasnica and Prolacta both say they don't believe it's scare. They point out women continue to pour human milk down the drain for lack of ease of donation or sale. A prominent Canadian parenting writer suggests the problem is not with a scarcity of milk, but a lack of advanced distribution channels. When "human milk" is in the same sentence as "scarce commodity" it seems to trigger the saliva glands of entrepreneurs and marketers. In 2010 the US FDA considered regulation and decided against it, concerned that it would put too much red tape in the way of the non-profits. Some states are considering rules. There is very little regulation of human milk nationally, and globally, the World Health Organization hasn't issued any meaningful statements or offered guidelines.

It's only been in the last dozen years that medical professionals, scared off human milk during the AIDS crisis and wooed by free-spending infant formula giants with an endless stream of specialized products, have started demanding donor milk. There isn't a single standard of care or guidelines for appropriate infant feeding in the NICU. As the jostling for market share continues, so will the disparaging of the existing milk banks. There is always room for improvement, and non-profit milk banks, with tight margins, are well aware that while other processes may be out there, they know they are not necessary to safely deliver donor human milk to NICU babies.

We should be constantly reviewing best practices around the world, and improving our systems - do we need expensive human-derived human milk fortifier? What about countries with good outcomes for very-low-birth-weight babies who don't use it, like Japan? Are there better ways to process milk to kill pathogens while retaining important and irreplaceable immune and nutrient components, like the new process being explored in Australia? Could we spend less pasteurizing while still having the same results, like in Brazil? What about Norway's extensive screening to rule out disease, like our blood banks do, so they can provide raw milk to babies? Clearly neonatologists working in that country don't agree that only sterile human milk belongs in the NICU.

We should not be using food products – even human milk derived food products – to feed some of the most fragile human beings on the planet, without thorough research, including determining whether the product is a safe and effective replacement for what is proven: mother's own milk and pasteurized donor human milk. If there is any question of increased risk or decreased effectiveness, the product shouldn't be used. Remember "SimplyThick, the tragedy no one saw coming?" More than two dozen babies died when the FDA approved – without testing – a thickener for breast milk and formula.

Research investments must be driven by the goal of saving and improving lives in the most cost-effective ways. Research funded by corporations which stand to profit from positive results should be given less weight when making decisions on the health of babies.

Soaring costs fuelled by corporations' dubious industrialized processes are an unnecessary burden on our healthcare system. There are valid concerns about exploitation of those whose breasts produce the raw milk, as well as of the tiny, fragile recipients of the resulting products. And the marketing hype is casting doubt on pasteurized donor human milk, and may even make mothers doubt whether their own milk is best for their own babies. Sometimes the best model is the simplest: mothers donating and sharing the bounty of the breast for the health and betterment of others. The question remains, how do we achieve this? I'll be exploring this in coming blog posts.

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Human Milk News shares content and thoughtful opinion focused on the marketing and commoditization of human milk. Human Milk News is curated by Jodine Chase, a communications consultant specializing in issues and crisis management news analysis. She is co-founder and communications lead for SafelyFed Canada.Jodine is a long-time breastfeeding advocate who, as a volunteer, has worked for many breastfeeding related causes including advocating for the re-establishment of our milk banks in Edmonton and Calgary and amending policies and legislation to protect breastfeeding rights. She is currently on the board of directors of the Breastfeeding Action Committee of Edmonton (BACE), and has volunteered for theBest for Babes Foundation, theILCA Social Media Alertteam,INFACT Canada,Protect Alberta Breastfeeding, Protect Breastfeeding in Canada, The Facebook vs. Breastfeeding Alliance, Friends of the WHO Code, World Milksharing Week, and the Best for Babes NIP Hotline's Canadian arm. She is or has been involved in a number of breastfeeding projects, events and causes including the Miracle Milk(TM) Mother's Day Stroll and Quintessence's Breastfeeding Challenge. Past involvements include providing communications support as a volunteer to Human Milk 4 Human Babies and the Alberta Breastfeeding Committee. Although Jodine is more often found behind the scenes assisting others to reach their communication goals, her various involvements include mainstream and social media and public speaking outreach. She is active live-tweeting and blogging about the breastfeeding events and conferences she attends, and she sometimes accepts honoraria for social media support and for public speaking engagements.